Shogo Nakamori Discusses Japan & Multi-national Trials

By Shogo Nakamori

October 8, 2015

Japan is the second largest pharmaceutical market and success in Japan is mandatory for pharmaceutical companies. Japan’s health authority requests data in the Japanese population; therefore, a certain number of Japanese patient's needs to be involved in multi-national trials. When Japan is involved in the study, we have several challenges to execute the trials. Since the study is managed by the team with multi-national countries, time-zone management and English communication are key challenges. Telephone conferences in English in very late at night are the biggest challenge for Japan team. Also decision and consensus making processes by Japanese are different from non-Japanese; therefore, misunderstandings can happen, and, if they stick to the Japanese way, it can cause a delay in a clinical trial.

One item is the same: Scientific and medical knowledge and experience are similar in Japan as in countries around the world.

Roughly 10 years ago, Japan was a “piggy back” for drug submissions to regulartory agencies and did not influence the overall data. Recently, Japan is a part of NDA package of each country and delay and inconsistency are not acceptable.

Global CROs in Japan, such as PAREXEL, have a lot of experiences to be involved in the multi-national trials, and we do have enough clinical staff to execute the trials with the global standard. We have very good internal training course to learn global standard of clinical trials.